What’s New for Biologics | FDA

What’s New for Biologics | FDA

Influenza Vaccine for the 2019-2020 Season Posted: 10/24/2019 CBER-Regulated Products: Resolved Shortages Posted: 10/24/2019

10/25/2019	October 24, 2019 Approval Letter - BEXSERO
10/24/2019	Influenza Vaccine for the 2019-2020 Season
10/24/2019	CBER-Regulated Products: Resolved Shortages
10/21/2019	Clinical Investigator Status (Biologics)
10/17/2019	September 24, 2019 Summary Basis for Regulatory Action - JYNNEOS
10/16/2019	BK190379 - DG Reader Net
10/16/2019	CBER Vacancy: Associate Director for Medical Policy – Title 38(F) Physician (GP-0602-15)
10/16/2019	Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review: Guidance For Industry; Technical Specifications Document
10/16/2019	Important Drug Information - Humate-P [Antihemophilic Factor/von Willebrand Factor Complex (Human)]
10/15/2019	October 15, 2019 Approval Letter - Adenovirus Type 4 and Type 7 Vaccine, Live, Oral